Post MI Clinical Trial
Official title:
Kardia - A Smartphone-based Care Model for Outpatient Cardiac Rehabilitation
This study hopes to target the remaining 80% of low risk post-myocardial infarction patients
who have refused uptake the traditional cardiac rehabilitation program In Changi General
Hospital. This is a 6-week home-based Cardiac rehabilitation program enabling patients to
track their blood pressure, physical activity and medicine compliance through a mobile
application. Each patient in the intervention arm is provided with a blood pressure monitor,
activity tracker and a single lead ECG monitor. The data from these devices would be
automatically synced by a mobile application and uploaded to a confidential web portal which
is only accessible by physician care-givers. The application also provides educational
content/tasks, appropriate reminders for taking medications and daily goals on activity
targets set by the care provider. This would help to engage the patients to enable
behavioural change and improve compliance to mediation and activity recommendations.
In general, 50 patients who are randomized to the intervention group (mHealth) will be
enabled with remote monitoring devices (ECG, Blood Pressure, Activity tracker) and "Kardia"
mobile application, for home-based rehabilitation program followed by review in the
outpatient Cardiology clinics. The control group (50 subjects) will just be monitored at
fixed intervals in the outpatient Cardiology clinics. Fu AT 3-4 months & 9-12 months.
Subjects will be advised to commence the exercise program 2 weeks after the myocardial
infarction. Block randomization using sequentially numbered sealed envelopes would be used to
assign subjects to the intervention or control arms. The primary outcome measure is
compliance and adherence to the "Kardia" program. Other endpoints include 6MWT, patient
wellbeing and behaviour (e.g. dietary habits, stress levels, physical activity) assessed
using questionnaires, major adverse cardiovascular events (MACE), modification of
cardiovascular risk profiles (i.e. LDL, BP, BMI, HbA1c, etc) and medicine compliance.
Cardiovascular disease (CVD) is the most common cause of death in Singapore, accounting for
~34% of deaths. This means 1 in every 3 deaths in Singapore is due to heart disease or
stroke. Ischemic heart disease is the leading cause of mortality and accounts for 17% of all
deaths attributable to life-style related risk-factors. The total burden of this disease is
likely to increase given the aging population and the increase in prevalence of obesity and
predisposing conditions such as diabetes mellitus, hypertension and hyperlipidaemia.
A number of modifiable environmental and patient specific factors increase the chance of
developing coronary artery disease. These include smoking, high blood cholesterol, physical
inactivity, diabetes, high blood pressure and obesity. Following myocardial infarction, acute
coronary syndromes, surgical and percutaneous interventions, cardiac rehabilitation has
provided an avenue for reducing future cardiovascular risks in patients by positively
influencing these factors. The eventual goal of the program is to engage patients with
permanent behavioural and life-style changes. There is strong evidence for the effectiveness
of cardiac rehabilitation which is given a Class 1 recommendation from the American/European
Cardiology guidelines, particularly for post-myocardial infarction patients. Several studies
and meta-analyses have demonstrated a significant reduction in mortality and morbidity.
Despite the clear benefits of cardiac rehabilitation programs, the uptake of these programs
has been poor due to various patient and system factors. Cardiac rehabilitation programs are
traditionally carried out in hospitals and health centres under the direct personal
supervision of mentoring clinicians. Patient barriers, such as time constraints and distance
from treatment centres lead to poor uptake of programs among eligible patients. To overcome
these barriers, home-based care models have been proposed as a viable alternative to
hospital-based cardiac rehabilitation programs even in the 1980s. The current state of mobile
phone communication and technology provides not only the capacity but an especially
attractive media option to support home-based cardiac rehabilitation programs.
This study aims to investigate a smartphone-based cardiac rehabilitation program for patients
recovering from myocardial infarction. The program focuses on providing patient centric
self-monitoring platform enabling patients to take control and be actively involved in their
medical care. The program ("Kardia") is a 6-week rehabilitation program enabling patients to
track their blood pressure, physical activity and medicine compliance through a mobile
application. Each patient in the intervention arm is provided with a blood pressure monitor
and activity tracker. The data from these devices would be automatically synced by a mobile
application and uploaded to a confidential web portal which is only accessible by physician
care-givers. The application also provides educational content/tasks, appropriate reminders
for taking medications and daily goals on activity targets set by the care provider. This
would help to engage the patients to enable behavioural change and improve compliance to
mediation and activity recommendations.
In Changi General Hospital, the uptake of cardiac rehabilitation among eligible patients is
less than 20%. This study hopes to target the remaining 80% of patients who have refused the
traditional cardiac rehabilitation program. It will be the first time that a smartphone based
home cardiac rehabilitation program would be offered in Singapore. If shown to be safe and
feasible, "Kardia" will help to improve patient outcomes in short to medium term. In
addition, it may empower the patients to take a more active role in their medical care and
promote long lasting behavioural changes in the long term. There will also be a significant
operation impact if "Kardia" can be rolled out as an alternative care model to the
traditional centre-based cardiac rehabilitation program, enabling greater patient access to
"cardiac rehabilitation". This is also in line with national initiatives to promote an active
and healthy lifestyle, i.e. National Steps Challenge by the Health Promotion Board.
The project is a randomized controlled study of smartphone based cardiac rehabilitation
program compared to routine care in patients who did not sign up for traditional
hospital-based cardiac rehabilitation. 50 patients who are randomized to the intervention
group (mHealth) will be enabled with remote monitoring devices (Blood Pressure and wearable
vital signs monitor, Biovotion) and "Kardia" mobile application, for home-based
rehabilitation program followed by review in the outpatient Cardiology clinics. The control
group (50 patients) will just be monitored at fixed intervals in the outpatient Cardiology
clinics.
Patients will be advised to commence the exercise program 2 weeks after the myocardial
infarction
Time Exercise Intensity Exercise Frequency/Duration Patient actions Week 1 light 3x/week; 10
minutes Exercise diary Week 2 light 3x/week; 20 minutes Week 3 light 3x/week; 30 minutes Week
4 moderate 3x/week; 15 minutes Week 5 moderate 3x/week; 30 minutes Week 6 moderate 4x/week;
30 minutes Week 7 moderate 5x/week; 30 minutes Week 8 moderate 5x/week; 30 minutes
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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|
Phase 3 |